Tools - UOS COMPC-UOSRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00842188112232), received between Jun 6, 2025 and Jun 6, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Naturally Worn” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 6, 2025Naturally Worn; Naturally Worn

  A SALES REP REPORTED ON (B)(6) 2025 THAT DURING A CASE THE COMPC-UOS WAS NOT COMPRESSING AS INTENDED DUE TO THE TOOL BEING WORN. IT WAS REPORTED THAT THIS CAUSED A 30-MINUTE DELAY IN SURGERY, THE DEVICE DID COME IN CONTACT WITH THE PATIENT PER PLANNED PROCEDURE BUT NO NEGATIVE IMPACT ON PATIENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22159225 ↗